eCTD Specialist - Cambridge, MA | Biospace
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eCTD Specialist

Voisin Consulting Life Sciences

Location:
Cambridge, MA
Posted Date:
11/18/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Other
Areas of Expertise Desired:

Job Description


Voisin Consulting Life Sciences assists Biotech, Pharma and Medtech manufacturers to develop, register and launch innovative products in North America and Europe. VCLS supports innovative life sciences companies throughout product development, from the design of global development strategies, to their implementation and submissions to regulatory agencies and payers.
With a team of 100+ professionals in the USA (Cambridge, MA; San Francisco, CA; Miami, FL & Somerville, NJ), Europe (South West London, UK; Paris & Rennes, France; Lausanne, Switzerland) and Bangalore, India, VCLS offers numerous career opportunities both to health product developers and support staff.
Our team is our greatest asset. VCLS is constantly looking for talented and motivated people, attracted by the very dynamic work environment of a fast-expanding truly international company.

Responsibilities:
•   Working in close collaboration with the Global Publishing team to provide the following support:
1.   Formatting MS Word documents
2.   Creating eCTD compliant PDFs
3.   Publishing electronic applications
4.   Dispatching electronic and CD/paper submissions to Regulatory Agencies (INDs, NDAs, BLAs, MAAs etc.)
•   Regularly providing up to date status reports to the Head of Publishing and Project Managers and maintaining submission trackers as required;
•   Ensuring regulatory submissions are published in accordance with the relevant ICH guidelines and maintaining familiarity with ICH and regional eCTD requirements;
•   Ensuring quality and timeliness of Client deliverables and submissions;
•   Contribute to Regulatory Intelligence and knowledge sharing within VCLS.

Requirements

•   A good working knowledge of electronic submission production tools, preferably docuBridge;  
•   Excellent/advanced MS Office and Adobe Acrobat skills;
•   Knowledge of Document Management System, preferably Sharepoint;
•   Experience with File Transfer Portals (FTPs);
•   Experience with submissions via Agency portals (especially the FDA’s ESG);
•   Good understanding of ICH and regional eCTD requirements;
•   Ability to manage multiple projects simultaneously;
•   Excellent communication skills and team player.

Personal attributes & Skills:
•   Excellent communication skills.
•   Strong formatting skills.
•   Good Knowledge of MS Office (Word, Excel, PowerPoint) is essential.
•   Proactive and enthusiastic approach to team working.
•   High motivation and flexibility.
•   Able to work in a multicultural environment
•   Team spirit

Attach your CV and cover letter when applying.